An observational study in Microbiota and Antibiotic Disruption, sponsored by University of Fribourg. Recruiting at 1 site in Switzerland. Open to participants aged 1 Day to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by University of Fribourg · Observational
The use of antibiotics causes profound changes in the microbiota. However, the magnitude of the effect of intrapartum and early-life antibiotics on the breast milk and the infant oral and intestinal microbiota, and whether effects are only short-term or persist long-term remain uncertain and will be determined in this study.
In this prospective cohort study, the investigators will determine the effect of (i) intrapartum antibiotics on the composition of the breast milk, and the infant oral and intestinal microbiota and antibiotic exposure in the first year of life on the composition of the infant intestinal microbiota (including the development and persistence of antibiotic resistance) and (ii) the association of this disruption with adverse health outcomes. (iii) The investigators will also determine the association between the maternal intestinal microbiota, the breast milk microbiota and the infant oral and intestinal microbiota.
University of Fribourg is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women who give birth at the Hôpital fribourgeois (HFR) in Fribourg, Switzerland and their infants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Antibiotic-induced disruption of breast milk microbiota
Composition of breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Antibiotic-Induced disruption the infant stool microbiota
Composition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Maternal to infant microbiota transfer
Similarities in the composition of the maternal intestinal, the breast milk microbiota and the infant intestinal microbiota, at 38 weeks of pregnancy, at birth and when infants are 7 days, 1, 2, 4 and 6 months of age.
Time frame: 2 years
The composition of the intestinal microbiota and adverse health outcomes
Abundance of certain microbes in the intestinal microbiota and number of episodes of lower respiratory tract infections until 2 years of age
Time frame: 2 years
The composition of the intestinal microbiota and adverse health outcomes
Abundance of certain microbes in the intestinal microbiota and number of episodes of acute otitis media episodes until 2 years of age
Time frame: 2 years
The composition of the intestinal microbiota and adverse health outcomes
Abundance of certain microbes in the intestinal microbiota and prevalence of allergic sensitisation (positive skin prick test) at 1 and 2 years of age
Time frame: 2 years
The composition of the intestinal microbiota and adverse health outcomes
Abundance of certain microbes in the intestinal microbiota and weight (in kg) at 1 and 2 years of age
Time frame: 2 years
Antibiotic-induced disruption of breast milk microbiota
Prevalence of antibiotic resistance genes within the breast milk microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Antibiotic-Induced disruption the infant stool microbiota
Prevalence of antibiotic resistance genes within the intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Introduction of different foods affects the composition of the intestinal microbiota
Age (in days) when a new food item was introduced and composition of infant intestinal microbiota when infants are 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Administration of oxygen affects the composition of the intestinal microbiota in infants
Number of days of oxygen and composition of infant intestinal microbiota when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Administration of antacids affect the composition of the infant intestinal microbiota
Number of days antacids were administered and composition of infant intestinal microbiota at birth and when infants are 7 days, 1, 2, 4, 6, 12 and 24 months of age.
Time frame: 2 years
Plan to share: No
Started Jan 2020 (actual). Primary completion is estimated for Dec 2025, 71 months after the start.
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University of Fribourg